YaoGeJuCDE public lists · weekly counts
National Drug-Review Weekly
The available CDE acceptance records list 462 drug applications between 2 December 2025 and 8 December 2025 (data as of 13 November 2026 06:00). Of these, generic applications numbered 102, covering 76 drug names.
2025/12/02 – 2025/12/08
- New acceptances this week
- 462
- Drugs with new generic filings (by drug name, de-duplicated)
- 76
- Accepted this week, now under review
- 126
DefinitionAcceptance numbers accepted this week that still appear on CDE's under-review list at the data cutoff; counted by acceptance date from the daily full pull of that list, independent of snapshot history.
Names with a public page are linked.
New acceptances this week
By application type and drug type
462filings, 102 of them generic
By application type
| Application type | Filings |
|---|---|
| Supplement | 222 |
| Generic | 102 |
| New drug | 84 |
| Import | 25 |
| Import re-registration | 15 |
| Unspecified | 14 |
By drug type
| Drug type | Filings |
|---|---|
| Chemical drug | 263 |
| TCM | 120 |
| Therapeutic biologic | 63 |
| Biologic | 10 |
| In vitro diagnostic reagent | 4 |
| Prophylactic biologic | 2 |
DefinitionAcceptance numbers whose acceptance date falls in this week; application type and drug type are the CDE list's own text, with empty values shown as “Unspecified”.
Most new generic filings, by drug
76 drugs with new generic filings; top 10 listed
| # | Drug | New generic filings | Filing companies | Under review, all years |
|---|---|---|---|---|
| 1 | Norepinephrine Bitartrate Injection | 5 | 3 | 9 |
| 2 | Riociguat Tablets | 3 | 1 | 4 |
| 3 | Metformin Hydrochloride And Empagliflozin Extended Release Tablets | 3 | 1 | 12 |
| 4 | Mupirocin Ointment | 2 | 2 | 30 |
| 5 | Tadalafil Tablets | 2 | 1 | 23 |
| 6 | 多种微量元素注射液(IV) · No verified English name | 2 | 1 | 4 |
| 7 | 奥洛他定莫米松鼻喷雾剂 · No verified English name | 2 | 1 | 1 |
| 8 | 左羟丙哌嗪糖浆 · No verified English name | 2 | 1 | 0 |
| 9 | 恩曲替尼胶囊 · No verified English name | 2 | 1 | 6 |
| 10 | Lafutidine Tablets | 2 | 1 | 2 |
DefinitionThis week's acceptance numbers with application type “Generic”, grouped by identical drug name; filing companies are de-duplicated by first applicant; under review, all years = acceptance numbers for that name, from any year, still on the CDE under-review list. Top 10 by filings, then companies.
Most new acceptances, by company
267 companies with new acceptances; top 10 listed
| # | Company (first applicant) | Filings | Drugs | Generic |
|---|---|---|---|---|
| 1 | Fu Song Xian Zhong Yao Co., Ltd. romanized | 30 | 30 | 0 |
| 2 | Eli Lilly and Company | 12 | 1 | 0 |
| 3 | Bai Ji Shen Zhou (Suzhou) Bio Technology Co., Ltd. romanized | 6 | 2 | 0 |
| 4 | Ai Min Pharma Group Co., Ltd. romanized | 5 | 5 | 0 |
| 5 | Beijing Sai Er Bio Pharma Co., Ltd. romanized | 5 | 4 | 5 |
| 6 | Suzhou Sheng Di Ya Biopharmaceuticals Co., Ltd. romanized | 5 | 4 | 0 |
| 7 | Terumo Corporation Kofu Factory | 5 | 1 | 0 |
| 8 | Hangzhou Nuo Ao Biopharmaceuticals Technology Co., Ltd. romanized | 5 | 1 | 0 |
| 9 | Shi Yao Group Bai Ke (Shandong) Biopharmaceutical Co., Ltd. romanized | 5 | 1 | 0 |
| 10 | Shanghai Ke Hua Bio Gong Cheng Co., Ltd. romanized | 4 | 4 | 0 |
DefinitionThis week's acceptance numbers grouped by first applicant; drugs are de-duplicated by drug name; “Generic” counts filings with application type “Generic”. Top 10 by filings.
Under-review list changes
Compared across this platform's snapshots of the under-review list
Data collected since 2026/10/22. There is not enough snapshot history for this week yet; counts of filings entering and leaving review start with the next complete week.
DefinitionEntered review = acceptance numbers seen for the first time in this platform's under-review snapshots this week, excluding the baseline records of the first snapshot day (2026/10/22). Left review = acceptance numbers whose last snapshot sighting falls in this week and that this snapshot no longer lists; the outcome follows NMPA's approval-document delivery notices, and numbers without such a record are marked to be checked. Companies are counted by first applicant.
Class 3 and new-drug acceptances
143 this week
| Accepted | Drug | Applicants |
|---|---|---|
| 2025/12/08Generic · Class 3 | 左羟丙哌嗪糖浆 · No verified English nameCYHS2504213 | Hubei Wei Sen Pharmaceutical Co., Ltd. romanized |
| 2025/12/08Generic · Class 3 | 左羟丙哌嗪糖浆 · No verified English nameCYHS2504212 | Hubei Wei Sen Pharmaceutical Co., Ltd. romanized |
| 2025/12/08Generic · Class 3 | Norepinephrine Bitartrate InjectionCYHS2504211 | Shandong Da Guan Pharmaceuticals Technology Co., Ltd. romanized; Shanxi Pu Heng Pharmaceutical Co., Ltd. romanized |
| 2025/12/08New drug · Class 3.1 | 温经汤颗粒 · No verified English nameCXZS2500050 | Shandong Run Zhong Pharma Co., Ltd. romanized |
| 2025/12/08New drug · Class 2.2 | 信迪利单抗注射液 · No verified English nameCXSL2501060 | Xin Da Biopharmaceutical (Suzhou) Co., Ltd. romanized |
| 2025/12/08New drug · Class 1 | 靶向BCMA的嵌合抗原受体T细胞注射液 · No verified English nameCXSL2501059 | Shenzhen Pu Rui Jin Bio Pharma Co., Ltd. romanized |
| 2025/12/08New drug · Class 3.3 | 重组抗CD38全人单克隆抗体注射液-皮下注射 · No verified English nameCXSL2501058 | Shanghai Fu Hong Rui Lin Bio Technology Co., Ltd. romanized; Shanghai Fu Hong Han Lin Biopharmaceuticals Co., Ltd. romanized; Shanghai Fu Hong Han Lin Bio Technology Co., Ltd. romanized |
| 2025/12/08New drug · Class 2.2 | 贝伐珠单抗注射液 · No verified English nameCXSL2501057 | Xin Da Biopharmaceutical (Suzhou) Co., Ltd. romanized |
| 2025/12/08New drug · Class 1 | 重组人源化抗HER2双特异性抗体注射液 · No verified English nameCXSL2501056 | Shanghai Jin Man Te Bio Technology Co., Ltd. romanized |
| 2025/12/08New drug · Class 1 | SYS6023 · No verified English nameCXSL2501055 | Shi Yao Group Ju Shi Biopharmaceutical Co., Ltd. romanized |
| 2025/12/08New drug · Class 1 | MRG006A · No verified English nameCXSL2501054 | Le Pu Bio Technology Co., Ltd. romanized |
| 2025/12/08New drug · Class 1 | DXC006 · No verified English nameCXSL2501053 | Hangzhou Duo Xi Bio Technology Co., Ltd. romanized |
| 2025/12/08New drug · Class 2.2 | 阿得贝利单抗注射液 · No verified English nameCXSL2501052 | Shanghai Sheng Di Pharmaceuticals Co., Ltd. romanized |
| 2025/12/08New drug · Class 1 | HZ-A-018胶囊 · No verified English nameCXHL2501345 | Hangzhou He Zheng Pharmaceuticals Co., Ltd. romanized |
| 2025/12/08New drug · Class 1 | HZ-A-018胶囊 · No verified English nameCXHL2501344 | Hangzhou He Zheng Pharmaceuticals Co., Ltd. romanized |
| 2025/12/08New drug · Class 2.4 | 注射用西罗莫司(白蛋白结合型) · No verified English nameCXHL2501343 | Shi Yao Group Zhong Qi Pharmaceutical Technology (Shijiazhuang) Co., Ltd. romanized |
| 2025/12/06Generic · Class 3 | Glycopyrronium Bromide and Neostigmine Metilsulfate InjectionCYHS2504210 | NANJING ZENKOM PHARMACEUTICAL CO.,LTD. |
| 2025/12/06Generic · Class 3 | 多种微量元素注射液(IV) · No verified English nameCYHS2504209 | Nanjing En Tai Pharmaceuticals Technology Co., Ltd. romanized; CISEN PHARMACEUTICAL CO., LTD. |
| 2025/12/06Generic · Class 3 | 多种微量元素注射液(IV) · No verified English nameCYHS2504207 | Nanjing En Tai Pharmaceuticals Technology Co., Ltd. romanized; CISEN PHARMACEUTICAL CO., LTD. |
| 2025/12/06Generic · Class 3 | Norepinephrine Bitartrate InjectionCYHS2504204 | Sichuan Yi Sheng Zhi Tong Pharmaceuticals Bio Technology Development Co., Ltd. romanized; Chengdu Shi Hai Tong Pharma Co., Ltd. romanized |
| 2025/12/06Generic · Class 3 | Norepinephrine Bitartrate InjectionCYHS2504203 | Sichuan Yi Sheng Zhi Tong Pharmaceuticals Bio Technology Development Co., Ltd. romanized; Chengdu Shi Hai Tong Pharma Co., Ltd. romanized |
| 2025/12/06Generic · Class 3 | 依巴斯汀口崩片 · No verified English nameCYHS2504202 | Shandong Lang Nuo Pharmaceutical Co., Ltd. romanized |
| 2025/12/06Generic · Class 3 | 二硫化硒洗剂 · No verified English nameCYHS2504199 | Shenzhen Da Fu Pharma Co., Ltd. romanized; Yu Song Yuan Pharma Co., Ltd. romanized |
| 2025/12/06Generic · Class 3 | Metformin Hydrochloride And Empagliflozin Extended Release TabletsCYHS2504197 | Hubei Wu Shi Pharma Co., Ltd. romanized |
| 2025/12/06Generic · Class 3 | Metformin Hydrochloride And Empagliflozin Extended Release TabletsCYHS2504196 | Hubei Wu Shi Pharma Co., Ltd. romanized |
| 2025/12/06Generic · Class 3 | Metformin Hydrochloride And Empagliflozin Extended Release TabletsCYHS2504195 | Hubei Wu Shi Pharma Co., Ltd. romanized |
| 2025/12/06New drug · Class 3.1 | 清金化痰颗粒 · No verified English nameCXZS2500049 | Shandong Feng Huang Pharmaceutical Co., Ltd. romanized |
| 2025/12/06New drug · Class 1.1 | 九味儿感颗粒 · No verified English nameCXZL2500125 | Chongqing Shi Zhong Yao Research Institute (Chongqing Shi Zhong Yao Bo Wu Guan) romanized; Sichuan Sheng Zhong Pharmaceuticals Ke College (Sichuan Sheng Zhong Yao Research Institute) romanized |
| 2025/12/06New drug · Class 2 | 乙型肝炎病毒表面抗原诊断试剂盒(化学发光法) · No verified English nameCXSS2500135 | Shanghai Ke Hua Bio Gong Cheng Co., Ltd. romanized |
| 2025/12/06New drug · Class 3.3 | 冻干人用狂犬病疫苗(2BS细胞) · No verified English nameCXSS2500134 | Chengdu Bio Zhi Pin Research Institute Co., Ltd. romanized |
113 more not listed (at most 30 rows).
DefinitionThis week's acceptance numbers with application type “New drug”, or registration applications whose class starts with 1, 2 or 3 (supplements and re-registrations excluded); newest first, at most 30 rows.
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